Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, a
FDA device recall Z-1771-2013 · posted 2013-07-19 · Terminated
Recall details
- Recalling firm
- Del Mar Reynolds Medical, Ltd.
- Reason for recall
- Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
- Action taken
- Spacelabs Healthcare sent an Urgent Medical Device Correction" letter, dated June 20, 2013, to all affected consignees. The letter identified the product, th problem, and the action to be taken by the consignee. Consignees were instructed to advise their staff of the situation. Consignees were also advised that Spacelabs Field Service personnel would be contacting them at their facility to schedule installation of a software update to resolve the issue at not cost to the consignee. Consignees with questions were instructed to call Technical Support at 1-800-522-7025 and select option 2. For questions regarding this recall call 800-522-7025.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 9 units (4 in the US and 5 outside US)
- Distribution
- Worldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
- Date initiated
- 2013-06-07
- Date posted
- 2013-07-19
- Date terminated
- 2013-08-29
- Location
- Hertford, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS ARKON ANESTHESIA WORKSTATION (K113051) | Spacelabs Healthcare | 2012-03-22 |